High Court of Australia Rejects Myriad Genetics BRCA1 Gene Patents
In 2013, the U.S. Supreme Court invalidated patent claims to isolated BRCA1 and BRCA2 breast cancer genes in the case of Association for Molecular Pathology v. Myriad Genetics, on the basis that genes are not patentable subject matter (see here). Now, the High Court of Australia (HCA) has issued a decision in a case that challenged the legitimacy of patent claims to isolated genes. This month, in the case of D’Arcy v. Myriad Genetics, Inc., the HCA invalidated similar Myriad patent claims on the isolated BRCA1 gene. In contrast to the U.S. patent, the Australian claims were confined to mutated or polymorphic BRCA1 genes that are indicative of cancer risk, but which are central to a patenting strategy that would control much of current BRCA1 genetic testing. The Court’s summary:
Today the High Court unanimously allowed an appeal from a decision of the Full Court of the Federal Court of Australia. The High Court held that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, was not a "patentable invention" within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth) ("the Act").
The term "nucleic acid" includes two kinds of molecules, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), which are found inside a human cell. A gene is a functional unit of DNA which encodes a particular protein produced by the cell. The protein produced depends on the sequence of nucleotides. The BRCA1 gene codes for the production of a protein called BRCA1.
The first respondent filed a patent which contained 30 claims. Relevantly, Claims 1 to 3 concerned a nucleic acid coding for a BRCA1 protein, and with one or more specified variations from the norm in its nucleotide sequence, isolated from its cellular environment. Those specified variations, characterised as mutations or polymorphisms, are indicative of susceptibility to breast cancer and ovarian cancer.
Section 18(1)(a) of the Act requires that, for an invention to be patentable, it must be "a manner of manufacture" within the meaning of s 6 of the Statute of Monopolies. The appellant commenced proceedings in the Federal Court of Australia challenging the validity of Claims 1 to 3 on the basis that the invention claimed did not meet the requirement of s 18(1)(a).
The primary judge dismissed the appellant's challenge, holding that the invention fell within the concept of a "manner of manufacture”. The Full Court dismissed an appeal from that decision. The Full Court held that an isolated nucleic acid was chemically, structurally and functionally different from a nucleic acid inside a human cell. The invention was a manner of manufacture because an isolated nucleic acid with the characteristics specified in Claims 1 to 3 resulted in an artificially created state of affairs for economic benefit.
By grant of special leave, the appellant appealed to the High Court. The Court unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a manner of manufacture. The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed. A plurality of the Court considered that to attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination.
In the reasoning behind the Australian decision, the Court invoked some similar themes from the U.S. 2013 decision, such as favoring an interpretation of the claims as drawn to information rather than a chemical:
It follows that in reality the claim in suit is no more expressed in terms of a chemical formula than was the claim in respect of the BRCA1 gene simpliciter which was rejected in the United States.
The scope of the claims were also cited as concerns:
Myriad acknowledges that a sample taken from a patient will infringe claim 1 if one or more of the specific mutations and polymorphisms identified in the claim are present, even if the testing is not directed at the BRCA1 gene or the identified mutations and polymorphisms. That is a problem.
Another international challenge to gene patenting (both product and method claims) remains on deck from Canada, in a case filed by the Children’s Hospital of Eastern Ontario (CHEO) against the University of Utah Research Foundation, Genzyme Genetics and Yale University over the patents covering five genes related to Long QT syndrome, a cardiac disorder. That case is also noteworthy in presenting a patent challenge from a government health provider (CHEO), reflecting the government-centered structure of Canada's healthcare system, where provincial governments assume responsibility in this sector.
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